EAST GRADE Course 2019 PICO Question Formulation

1. EAST GRADE Course 2019PICO Question Formulation Nimitt Patel MD and Sofya Asfaw MD

2. Disclosures • Content of this presentation is partly adapted from gradepro.org and/or lecture material presented at previous GRADE Pro course(s)

3. Topic and Framing the Question • Guideline recommendations should answer a focused and sensible health care question that leads to an action • PICO framework is an accepted methodology for framing health care questions • Contains four components

4. PICO • P – Population (the patient/population to which the recommendations would apply) • I – Intervention (the intervention under investigation – therapeutic, diagnostic) • C – Comparator (alternative intervention, control group intervention) • O – Outcome (outcome or outcomes of interest)

5. Framing the Question • Population • Condition - disease, including explicit diagnostic criteria • Population - age race, sex • Setting - community, hospital, outpatient • Intervention • Timing of exposures, route of administration • Dose, duration of exposure or therapy • Components of a complex intervention • Comparison • No intervention • Standard therapy • Placebo • Active comparator • Outcomes • Mortality • Morbidity • Patient reported outcomes, functional outcomes • Individual level vs community level outcomes

6. PICO Question Generation • Grade Guideline Development Tool allows for selection of two different formats for questions about management: • Should [intervention] vs. [comparison] be used for [health problem]? • Should [intervention] vs. [comparison] be used in [population]? • And formats for questions about diagnosis: • Should [intervention] vs [comparison] be used to diagnose [ target condition] in [health problem and/or population]?

7. Example • 52 year old male with a colon cancer and a remote history of DVT after trauma asks if he should be on heparin to decrease his risk of developing a clot. What is your PICO? • How do we frame the question? • P – adult outpatient with cancer • I – prophylactic heparin • C – no heparin • O – morbidity, VTE, major bleeding, quality of life

8. Lumping v Splitting • Lumping: broad question with range of interventions • Splitting: narrow question with narrow range of interventions • Advantages of Lumping: • Informative when large range of options • Useful for policymakers • Mitigates double efforts • Disadvantages of Lumping/Splitting: • May be invalid (minimizing different groups) • Time consuming and complex • Interpretation may be difficult • Can be too specific with too many questions and lack of supporting data if “over split”

9. Refining the Question • Avoid post hoc change of question • May need to refine question as new studies are identified • May need to consider repeating literature search if this is the case

10. Outcomes Selection • Be Comprehensive • Expand outside the literature • Additional input from patient/clinicians/public • Safety considerations (often under-reported) • Patient-important • Desirable or undesirable

11. Prioritizing Outcomes • Critical, important, less important • Process should be driven by importance over evidence • Numerical application (1-9 scale): • 1-3 not important • 4-6 important, but not critical for making a decision • 7-9 critical for making a decision • Voting should be done responding to team leader individually • Typically critical outcomes considered in the final recommendation • IMPORTANT: You are NOT ranking the outcomes you are rating them!!!!!!!!

12. Questions?